The present invention encompasses articles which are used in the vagina to deliver biologically active agents, especially contraceptives. By virtue of their unique construction and resulting shape, the articles remain in position, even during intercourse, so that delivery of the biologically active agent is not interrupted.
The articles of this invention are designed for use in the vagina, can be inserted by the user, and do not require fitting by a physician as, for example, in the case of intrauterine contraceptive devices. The articles are designed to remain in the vagina during the time between menstrual periods to provide desirable, prolonged release of a biologically active agent, and their construction and shape facilitate retention therein. It will be appreciated that when the biologically active agent is a contraceptive, an effective between-period contraceptive device is provided.
The copending application of Robert G. Laughlin, entitled CONTROLLED RELEASE ARTICLE, Ser. No. 560,020, filed Mar. 19, 1975, describes "controlled release" articles which are especially useful as contraceptives. By the present invention, articles operating by the controlled release mechanism described by Laughlin are constructed in such manner and configuration that said articles can be worn continuously during the period between menses and can be left in place in the vagina during intercourse. The unique construction obviates the need for removal and re-insertion and allows uninterrupted delivery of the contraceptive agent. The construction and shape also promote retention deep within the vaginal cavity, a position which favors contraceptive efficacy and wearing comfort.
Lichtman, et al., Contraception 8(4) 291-7 (1973), the disclosures of which are incorporated herein by reference, describe a vaginal contraceptive device comprising a soluble film containing a nonionic surfactant as a spermicide. Such devices can also be fashioned from slow-dissolving films into shapes corresponding to the articles herein so that they can be retained in the vagina during intercourse.
A series of patents relating to drug delivery, especially to the area surrounding the eye, describe various means whereby medicaments and the like can be enclosed within permeable membranes to yield so-called "sustained release" devices. See, for example, U.S. Pat. No. 3,828,777 MICROPOROUS OCULAR DEVICE, issued Aug. 13, 1974 to R. A. Ness; U.S. Pat. No. 3,618,604 OCULAR INSERT, issued Nov. 9, 1971 to R. A. Ness; U.S. Pat. No. 3,416,530 EYEBALL MEDICATION DISPENSING TABLET, issued Dec. 17, 1968 to R. A. Ness; U.S. Pat. No. 3,832,252 METHOD OF MAKING A DRUG DELIVERY DEVICE, issued Aug. 27, 1974 to T. Higuchi and H. M. Lieper (see also U.S. Pat. No. 3,598,122, issued 10/1971, other references cited in Higuchi, et al., as well as U.S. Pat. No. 3,867,519) the disclosures of said patents being incorporated herein by reference. Following the practice of this invention, the devices described in the foregoing patents can all be fashioned into articles of the present type, thereby allowing prolonged release of various desirable medicaments, and the like, into the vaginal area, which are comfortably worn and dependably retained even during intercourse.
The concurrently-filed application of Gougeon, entitled DISPENSING MEANS, Ser. No. 636,899, filed 12-02-75, also relates to vaginal contraceptives, and the like, constructed in a manner so as to be vaginally-retainable.
The concurrently-filed application of Drobish, entitled DISPENSING MEANS, Ser. No. 636,897, filed 12-02-75, also relates to vaginal contraceptives, and the like, constructed in a manner so as to be vaginally-retainable.
The copending application of Hughes, Ser. No. 578,297, filed May 16, 1975, relates to shaped vaginal contraceptives, and the like.